Label: AVEENO CALM PLUS RESTORE DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 69968-0813-1, 69968-0813-2
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 18, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Titanium Dioxide

    Zinc Oxide

    Active ingredientsPurpose
    Titanium Dioxide (5.8%)Sunscreen
    Zinc Oxide (12.5%)Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    • On damaged or broken skin

    When using this product

    ▪ Keep out of eyes. Rinse with water to remove.

    and ask a doctor if

    ▪ Rash occurs

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    For sunscreen use:

    ▪ Apply generously and evenly 15 minutes before sun exposure

    ▪ Reapply at least every 2 hours

    ▪ Use a water resistant sunscreen if swimming or sweating

    ▪ Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and

    early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum

    SPF value of 15 or higher and other sun protection measures including:

    ▪ limit time in the sun, especially from 10 a.m.–2 p.m.

    ▪ wear long-sleeved shirts, pants, hats, and sunglasses

    ▪ children under 6 months of age: Ask a doctor.

  • Other information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Glycerin, Ethylhexyl,Methoxycrylene, Dimethicone, Triacontanyl PVP, Glyceryl Stearate, Calcium Sodium Borosilicate, PEG-100 Stearate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Avena Sativa (Oat) Kernel Extract, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Tocopheryl Acetate, Xanthan Gum, Cetearyl Olivate, Sorbitan Olivate, Stearic Acid,Triethoxycaprylylsilane, Ethylhexylglycerin, Sodium Chloride, Phenoxyethanol, Cetearyl Alcohol, Chlorphenesin, Disodium EDTA, Aluminum Hydroxide, Iron Oxides

  • Questions?

    866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    JOHNSON & JOHNSON CONSUMER INC.

    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 48mL Carton Label

    ​ New

    Aveeno ®

    Calm +

    Restore

    DAILY

    MOISTURIZER

    mineral sunscreen

    BROAD SPECTURM

    SPF 30

    ZINC OXIDE

    TITANIUM DIOXIDE

    Sensitive Skin

    Lightweight

    all day moisture

    FRAGRANCE FREE

    SPF

    30

    DERMATOLOGIST RECOMMENDED BRAND

    SOOTHING OAT+ FEVERFEW

    1.7 FL. OZ (48 mL)

    Aveeno

  • INGREDIENTS AND APPEARANCE
    AVEENO CALM PLUS RESTORE DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE58 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE125 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    OAT (UNII: Z6J799EAJK)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0813-21 in 1 CARTON06/01/2023
    148 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0813-112 in 1 TRAY06/01/2023
    214 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!